Warning: Cannot assign an empty string to a string offset in /homepages/24/d109934528/htdocs/icfda/wp-includes/class.wp-scripts.php on line 426Newsvine Archives - International Coalition for Drug Awareness - ICFDA

Tag Archives: Newsvine

The only word for this news is “Criminal!” I hope they are watching these children 24-7 to keep them from committingsuicide or homicide while in the study. I recall the seven year old boy on Paxil I worked with who wanted to cut the baby out of his mother’s belly and the 17 year old who impulsively jumped off an overpass in front of a semi-truck to end his life. Then there was the 10 year old brother and 15 year old sister, both on Paxil, who stabbed their 7 year old brother and buried him in the back yard. Sounds like a great drug for kids, doesn’t it?

I just finished a court report (I have been testifying as an expert in these cases for almost two decades) on a Paxil case and noted that 18 of the listed side effects were indicators of mania. If Glaxo had labeled those effects for what really are instead of the labels they gave those reactions then no one would be surprised to know that in children the rate of Bipolar Disorder increased 4000% from 1996-2004.

As for Paxil being beneficial apparently someone missed the news that came out just over two years ago where the original studies done on SSRI antidepressants finally surfaced – many the FDA had never seen – indicating that the drugs offer no more benefit than a placebo. So if even the worst drugs perform better than placebo, where does that leave the SSRI antidepressants?

The trial criteria listed on ClinicalTrials.gov, however, provide an interesting lesson in how managers can carefully design drug trials designed to flatter their products — something good companies don’t do.

The primary aim of the study is not to find out why Paxil makes some children kill themselves. Rather, it’s yet another efficacy study, which the drug doesn’t need because it was approved years ago — we already know the drug works.

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

Book Excerpts

BOOK TESTIMONIALS

"VERY BOLD AND INFORMATIVE"

"PRICELESS INFORMATION THAT IS GIVING ME BACK TO ME"

"THE ABSOLUTE BEST REFERENCE FOR ANTIDEPRESSANT DRUGS"

"WELL DOCUMENTED &
SCIENTIFICALLY RESEARCHED"

"I was stunned at the amount of research Ann B. Tracy has done on this subject. Few researchers go to as much trouble agressively gathering information on the adverse reactions of Prozac, Zoloft and other SSRIs."
More Book Testimonials